Events

Rappel de ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew Surgical Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00406-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00406-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Smith & nephew internal investigation found the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. to date there have been no complaints or adverse effects associated with this issue.This could potentially lead to a post-operative infection.To date there have been no complaints or adverse effects associated with this issue.
  • Action
    Smith & Nephew is advising their customers to inspect the inventory and quarantine the affected devices immediately. A Smith & Nephew customer service representative will contact the customer to arrange collection of any affected products and advise on substitute devices available. This action has been closed-out on 11/08/2016.

Device

ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Modèle / numéro de série
    ULTRA FAST-FIX Knot Pusher/Suture Cutter, StraightProduct No: 72201537All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019ARTG Number: 112714
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd